Liberal or Restricted Fluid Intake in Patients With Heart Failure: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 1
- 主要终点
- B-lines
研究概览
简要总结
Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart failure. The medical treatment has progressed and improved over the years and considerably over the last few years, which has decreased symptoms and improved physical function of these patients. Despite our great success in the medical treatment of heart failure, we still face challenges in hospital readmissions and treatment strategies. It contributes to the increased need of evidence on, if and how, fluid intake and fluid restriction should be used as a self-care method. Fluid restriction as a self-care treatment is still commonly recommended in heart failure management although the scientific clinical evidence is lacking. Fluid restriction is associated with a higher degree of thirst and lower rated quality of life, and there is no consensus on how fluid restriction should be used, no plan for individualized treatment and no agreement on how fluid restriction should be a part of the patient self-care treatment. There is therefore a need for knowledge on how heart failure patients are affected by fluid restriction regarding clincal signs and symptoms of heart failure, quality of life, physical function, readmission to hospital or heart failure events. The primary aim of the study is to investigate whether a free fluid intake is safe compared to a restricted fluid intake, regarding clinical signs of heart failure measured as the presence of B-lines and/or an increase in NT-proBNP. The secondary aim is to clarify whether an unlimited fluid intake can improve quality of life and reduce thirst without affecting heart failure symptoms, physical activity, hospital readmissions and/or heart failure events.
详细描述
Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart failure. The medical treatment has progressed and improved over the years and considerably over the last few years, which has decreased symptoms and improved physical function of these patients. Despite the improvement in medical treatment, we still face challenges in readmission to hospital and in treatment strategies. It contributes to the increased need of evidence on, if and how, fluid intake and fluid restriction should be used as a self-care method. Fluid restriction as a self-care treatment is still commonly recommended in heart failure management although the scientific clinical evidence is lacking. Fluid restriction is associated with a higher degree of thirst and lower rated quality of life, and there is no consensus on how fluid restriction should be used, no plan for individualized treatment and no agreement on how fluid restriction should be a part of the patient self-care treatment. There is therefore a need for knowledge on how heart failure patients are affected by fluid restriction regarding quality of life, physical function, signs and symptoms and readmission to hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with left ventricual heart failure (HFrEF, HFmEF)
- •Physical, cognitive and linguistic ability to carry out all aspects of the study
排除标准
- •Reversible cause of HF (thyroid disorders, severe anemia, etc.)
- •Hyponatremia at baseline (sodium <130 mmol/L)
- •eGFR at baseline <30mL/min/1.73m2
- •Scheduled cardiac surgery, coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) within 3 months
- •Myocardial infarction within 3 months
- •Comorbidity for which fluid restriction or unlimited fluid intake is advised
- •Life expectancy <6 months
研究组 & 干预措施
Free fluid intake
Patients have no restrictions of fluid intake
干预措施: Free fluid intake (Behavioral)
Restricted fluid intake
Patients are recommended a restricted fluid intake of 1500 mL/day
结局指标
主要结局
B-lines
时间窗: 12 weeks
The patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion
NT-proBNP
时间窗: 12 weeks
Specific biomarkers for heart failure (blood test)
次要结局
- HRQoL(12 weeks)
- Heart failure symptoms(12 weeks)
- Thirst distress(12 weeks)
- Self-Care(12 weeks)
- IVC(12 weeks)
- Pleural effusion(12 weeks)
- Physical Capacity(12 weeks)
- Hospital readmissions(12 weeks)
- Heart failure events(12 weeks)
研究者
Carolin Nymark
Director of Nursing Development
Region Stockholm